Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Foraminal Stenosis
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS) scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
Investigators
Xiaofei Cheng
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
- •Has presence of active malignancy
- •Has a history of severe allergy
- •Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
- •Pregnant, or may become pregnant within follow-up period of study
- •Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
- •Spondylolisthesis at the target level
- •Has undergone previous lumbar surgery
- •Has severe osteoporosis (T-score ≤ -3.5)
- •BMI \> 35kg/m2
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS) scores
Time Frame: 2 years postoperatively
Secondary Outcomes
- Operative duration(1 week postoperatively)
- Estimated blood loss(1 week postoperatively)
- Foraminal height(2 years postoperatively)
- Fusion rate(2 years postoperatively)
- Adverse events related to procedure(2 years postoperatively)
- Spinal angles(2 years postoperatively)
- Oswestry Disability Index (ODI)(2 years postoperatively)
- Cost of treatment(2 years postoperatively)
- Length of hospital stay(1 week after discharge)
- Intervertebral space height(2 years postoperatively)